The U.S. Food and Drug Administration (FDA) inspected your establishment located in Somerset, New Jersey, from August 4, through August 31, 2010. The FDA investigators determined that you manufacture in vitro diagnostic (IVD) test kits, including the CareStart HIV test kits, CareStart Syphilis test kits, CareStart Malaria test kits, and CareStart HCV test kits which are devices within the meaning of section 201(h) [21 U.S.C. 321] of the Federal Food, Drug, and Cosmetic Act (the ACT) because they are instruments intended for use in the diagnosis of disease.

Under section 513(f) of the Act, the HIV test kits are class III devices, which under section 501(f)(1)(B) are deemed to be adultered unless they have received premarket approval under section 515 or an investigational device exemption (IDE) under section 520(g). Your CareStart HIV test kits are not approved for sale in the United States and have not received an investigational device exemption from premarket approval. These statutory provisions protect the public health and ensure that new medical devices are safe and effective.

Additionally, this inspection also revealed that you have not obtained marketing approval or clearance before you began offering the CareStart Syphilis test kit, CareStart Malaria test kit, and CareStart HCV test kit for sale, which is a violation of the law. The Act requires that manufacturers of devices that are not exempt obtain marketing approval or clearance for their products from the FDA before they may offer them for sale. This helps protect the public health by ensuring that new devices are shown to be both safe and effective or substantially equivalent to other devices already legally marketed.

Specifically, the CareStart Syphilis test kit, CareStart Malaria test kit, and CareStart HCV test kit are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). The devices are also misbranded under section 502(o) the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. 360(k).

For devices requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency. 21 C.F.R. 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your products may be legally marketed.

Furthermore, your CareStart HIV test kits are adulterated within the meaning of section 501(h) of the Act [21 U.S.C. 351(h)], in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice (CGMP) requirements of the Quality System Regulation (QS Regulation) found at Title 21, Code of Federal Regulations (CFR), Part 820. At the close of the inspection, FDA issued a Form FDA 483, Inspectional Observations, that described a number of significant objectionable conditions related to the facility’s compliance with CGMP.These violations include, but are not limited to, the following:

1. You failed to establish and maintain procedures to ensure that the device history records (DHRs) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record (DMR) [21 CFR 820.184]. For example:

A. You failed to implement procedure QOP-42-03, Control of Records, Rev. B, effective September 1, 2006, which requires a DHR to contain purchasing records, production (batch) records, product nonconformity and rework records, sterilization records, device verification and acceptance records, and device labeling records and these records were not maintained in your DHRs for the following lots of products:

i. Lot E10IA, CareStart HIV 2 Line product, production date of May 2010;

ii. Lot B10IA, CareStart HIV 2 Line product, production date of February 2010;

iii. Lot B70IB, CareStart HIV 3 Line product, production date of February 2010;

B. Your Device Master Record (DMR) for the CareStart HIV 2 Line product lists specific forms to be used in the documentation of in-process and final acceptance activities. However, the DHRs for CareStart HIV 2 Line product lots L18IA, J19IA, L19IA, C10IA did not contain the records for the device visual inspection for the assembled kits, the pouch sealing test, the red blood cell leaking test, and the in-process testing for the (b)(4) are performed in order to demonstrate that the devices were manufactured in accordance with the DMR.

C. You failed to follow procedures QOP-42-03, Control of Records, Rev. B, effective September 1, 2006, and QOP-75-01, Production Work Order and History Record, Rev. A, effective July 1, 2005, which require DHRs to contain production work orders for device verification, inspection, and testing where the work orders become the principal manufacturing, acceptance, traceability and release record in the DHR for the distributed devices. The production work orders were not maintained as part of the DHR for your CareStart HIV 2 Line products.

2. You failed to maintain DHRs for the primary identification label and labeling used for each production unit [21 CFR 820.184(e)]. Specifically, you failed to maintain copies of labels used for each lot or batch that include the lot number or expiration date.

3.You failed to maintain DMRs to include, or refer to the location of, the following information: device specifications including appropriate drawings; production process specifications including production methods, production procedures, and production environment specifications; quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used; packaging and labeling specifications, including methods and processes used [21 CFR 820.181]. Specifically, you failed to adequately implement procedure QOP-42-02, Device Master Record Rev. A, effective July 1, 2005, for your CareStart HIV 2 products by not including or referencing the documents specific to device specifications, manufacturing process specifications, quality assurance procedures and specifications, and packaging and labeling specifications.

4. You failed to follow the procedures to control all documents [21 CFR 820.40]. Specifically, you failed to implement procedure QOP, Control of Documents, Rev. A, effective July 1, 2005, which states in Section 4.2 that approved and released documents are to be identified with the name (or initials) of the approving/releasing authority and the effective date. For example, your DHRs were not reviewed and approved with a signature and dated by a designated individual prior to their issuance. These documents include records of production for the following: Lot B10IA, CareStart HIV 2 Line product; Lot E10IA, CareStart HIV 2 Line product; Lot B70IA, CareStart HIV 3 Line product; Lot H19IA0, CareStart HIV 1-2-0 product; and Lot B10IA0, CareStart HIV 1-2-0 product.

5. You failed to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements [21 CFR 820.50]. Specifically, you failed to establish a Supplier Quality File for (b)(4) a supplier of the (b)(4) used in the manufacturer of CareStart HIV 2 Line product. In addition, they were not listed on your approved supplier list form, QF-74-01-1, dated January 31, 2006, Rev. B. In addition, no acceptance activities were performed for incoming raw materials for the CareStart HIV 2 Line product, including identity testing of the (b)(4). Your firm approves incoming raw materials based on a specification of bulk materials, and Certificate of Analysis from the supplier.

This inspection also revealed that you did not obtain marketing approval before you began offering the CareStart HIV test kits for sale, which is a violation of the law. The Act requires that manufacturers of devices that are not exempt obtain marketing approval or clearance for their products from the FDA before they may offer them for sale. This helps protect the public health by ensuring that new devices are shown to be both safe and effective or substantially equivalent to other devices already legally marketed.

In addition, the FDA investigators conducted an assessment of your compliance with the export requirements listed in Section 802 of the Act for your CareStart HIV test kits. You do not meet the requirements of Section 802 of the Act because the device is not manufactured, processed, packed, or held in substantial conformity with CGMP requirements.

Furthermore, medical devices are not deemed adulterated and may be exported if they are in compliance with Section 801(e)(1) of the Act, 21 U.S.C. § 381(e)(1). However, because the outer shipping package for your CareStart Malaria pLDH/HRP2 combo Kit was not labeled for “export only” (intended for export), you cannot export your device unless you comply with the requirements under Section 801(e)(1) of the Act.

We acknowledge receipt of your written response dated September 15, 2010, which addresses the inspectional observations on the Form FDA 483 issued at the close of the inspection. We have reviewed your response and have the following comments. The items are numbered to correspond with the observations listed on the Form FDA 483.

FDA 483 item #1

You state that you plan to voluntarily withdraw from the market and destroy all implicated CareStart HIV test kit lots that you have in inventory, along with all CareStart HIV product labeling. Please keep in mind that the manufacture and future shipments of unapproved devices would be considered a violation of the Act.

FDA 483 item #2

Your response states that the CareStart HIV test kits are not for sale and distribution in the U.S. However, our inspection documented the sale of CareStart HIV test kits in the U.S. and overseas. CareStart HIV test kits, Lot E10IA, were sold on June 16, 2010, in (b)(4), and on March 1, 2010, to (b)(4). In addition, CareStart HIV test kits were shipped overseas on April 8, 2010, to (b)(4). Your response does not provide any evidence that you have performed any corrective actions for the observations cited on the Form FDA 483.

FDA 483 item #3

Your response states that you were “…not certain of the unsigned or non-dated records shown during the inspection. The employee who supplied these records has been terminated and is no longer involved with the company.” However, no evidence was provided to show that any preventive actions have been implemented to prevent the recurrence of the same issue.

FDA 483 item #5

Your response does not provide any assurance that you will implement your written procedure for purchasing controls. In order to ensure that purchased or otherwise received product or services conform to specifications, purchasing must be carried out under adequate controls, including the assessment and selection of suppliers, contractors, and consultants. The specifications for the finished device cannot be met unless the individual parts of the finished device meet specifications.

You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts.Additionally, premarket approval applications for class III devices to which the Quality System Regulation deviations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.

Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.

Your response should be sent to: Robert J. Maffei, Compliance Officer, U.S. Food and Drug Administration, 10 Waterview Boulevard, 3rd Floor, Parsippany, New Jersey, 07054. If you have any questions about the content of this letter, please contact Mr. Maffei via telephone at 973-331-4906 or via fax at 973-331-4969.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the FDA 483, issued at the closeout of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.